Acute Myeloid Leukemia (AML)Phase 1NCT05513612

Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

A Phase 1 study testing Autologous CAR-T cells, Fludarabine and Cyclophosphamide in people with Acute Myeloid Leukemia (AML) and B-cell Non-Hodgkin's Lymphoma (B-NHL), run by Shanghai Pudong Hospital at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM)
What is being tested?: Autologous CAR-T cells, Fludarabine and Cyclophosphamide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteChina
Study dates: 1 Aug 2020to 31 Dec 2026
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to understand and the willingness to sign informed consent.
Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT).
Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
Adequate organ functions:
Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen;
Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) > 30 mL/min/1.73 m^2;

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Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) <2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL;
Left ventricular ejection fraction (LVEF) > 40%.
Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.

Who cannot join

Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).
History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions).
History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.
Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
Uncontrolled fungal, bacterial, viral, or other infection.
Acute or chronic graft-versus-host disease (GVHD).

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History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease.
History or clinical evidence of CNS disease.
Female subjects who are pregnant or lactating.
Prior CAR-T therapy or other genetically modified T cell therapy.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 201399

Other trials in China

About this study

Official title: Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.

Read the detailed description

Chimeric antigen receptor (CAR)-modified T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety, efficacy, pharmacokinetic, and pharmacodynamic of the CAR-T cells will be assessed.

Conditions: Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), T-Cell Leukemia/Lymphoma, Adult, B-cell Acute Lymphoblastic Leukemia (B-ALL)
Being tested: Autologous CAR-T cells, Fludarabine, Cyclophosphamide
Keywords: CD123 CAR-T, CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, Hematopoietic and Lymphoid Malignancies
Medical subject headings: Leukemia, Myeloid, Acute, Lymphoma, B-Cell, Multiple Myeloma, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous CAR-T cellsBiological
CAR-T cells will be infused intravenously.
FludarabineDrug
Also called Fludara
Administered according to package insert
CyclophosphamideDrug
Also called Cytoxan
Administered according to package insert

Study groups in NCT05513612
Study group	Role	What they receive
Autologous CAR-T cells	Experimental	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells. Receives: Biological: Autologous CAR-T cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

TEAEs
Incidence and severity of Treatment Emergent Adverse Event.
Measured: 4 weeks
TRAEs
Incidence and severity of Treatment Related Adverse Events.
Measured: 4 weeks
AESIs
Incidence and severity of AEs of Special Interest.
Measured: 4 weeks

Secondary outcomes (3)

Duration of Overall Response (DOR)
Time from documentation of disease response to disease progression.
Measured: 12 months
Progression-Free Survival (PFS)
PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.
Measured: 12 months
Overall survival (OS)
OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202031 Dec 2026

First posted24 Aug 2022
Study start1 Aug 2020
Primary completion31 Dec 2025 (estimated)
Study completion31 Dec 2026 (estimated)

Why it stopped: The study is not initiated and we want it to be withdrawn.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05513612
Sponsor's protocol ID: 2020-IIT-002-E03
Status last verified: Feb 2023
First submitted: 22 Aug 2022
Last updated: 1 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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